Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma

NCT ID: NCT01711242

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2021-01-31

Brief Summary

The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection.

Detailed Description

Gastric cancer is one of the most common malignancies in China. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, the overall survival results remain unsatisfactory. The main factor accounting for high mortality rate is the relapse after surgical resection. During the past few decades, the principle of combined modality treatment has been developed and applied in gastric cancer. Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study had been challenged by the fact that the surgical treatment applied in the trial was gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients with extensive lymph node dissection. In ARTIST study, the addition of concurrent capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there was a statistically significant prolongation in disease-free survival in the concurrent treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve a significant survival benefit. The standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus, the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric cancer is essential.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

capecitabine/Oxaliplatin/radiotherapy

sequence chemoradiotherapy following radical resection

sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX.

Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.

Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

capecitabine/Oxaliplatin

chemotherapy alone following radical resection

Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Interventions

Capecitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Histologically proven gastric cancer; ≥ D2 resection
• Stage T1-4, N+
• 18 ≤ age ≤ 75
• Eastern Cooperative Oncology Group 0-2
• No distant metastasis
• Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
• Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
• Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
• Written informed consent

Exclusion Criteria

• Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;
• Active infection requiring antibiotics;
• Pregnant, lactating women;
• Psychiatric illness, epileptic disorders;
• Concurrent systemic illness not appropriate for chemotherapy;
• Resection margin (+);
• History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma;
• D0, D1 resection;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

xie congying

OTHER

Sponsor Role: lead

Responsible Party

xie congying

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

congying xie, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

xiaolei chen, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

Locations

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

WZMC-12068

Identifier Type: -

Identifier Source: org_study_id